Food and Drug Regulations (C.R.C., c. 870)

J.01.021. Every institution shall keep and retain for a period of two years from the date of the making of the record, a record of

• (a) the amount of every restricted drug received by the institution;

• (b) details of the use of restricted drugs in the institution;

• (c) the names and qualifications of every person who makes use of a restricted drug in the institution; and

• (d) full clinical data with respect to the use of every restricted drug received by the institution.

J.01.022. Every institution shall make its records referred to in section J.01.021 available to the Minister upon his request and shall permit such inspection of the institution, respecting its use of restricted drugs, as the Minister may require.

J.01.023. Every licensed dealer shall maintain a record of

• (a) the name, quantity and form of any restricted drug received by them, the name and address of the person who sold or provided it and the date it was received;

• (b) the name, quantity and form of any restricted drug sold or provided by them, the name and address of the person to whom it was sold or provided and the date it was sold or provided;

• (c) the name, quantity and form of any restricted drug they have used in making or assembling a product or compound containing that restricted drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

• (d) the name and quantity of any restricted drug produced and the date on which it was placed in stock; and

• (e) the name, quantity and form of any restricted drug he has in stock.

J.01.024. Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.

• J.01.025. (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

  • (a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; and

  • (b) the process and conditions of the producing, making, assembling or storing.

• (2) [Repealed, SOR/2010-222, s. 32]

J.01.026. Every person who sells or provides a restricted drug shall

• (a) supply such information in such form as the Minister may require respecting the dealings of any person in the restricted drug;

• (b) produce to an inspector any books, records or documents required to be kept under this Part;

• (c) permit an inspector to make copies of or to take extracts from any books, records and documents; and

• (d) permit an inspector to check all stocks of restricted drugs located on the premises described in his licence.